NEW YORK (AP) – A second drug company has confirmed it plans to market a new form of the powerful and addictive painkiller hydrocodone, worrying experts who fear a narcotics “arms race” that could worsen a national problem with prescription drug abuse.
Israel-based Teva Pharmaceuticals says its product, TD Hydrocodone, could be worth as much as $500 million annually in sales. The drug is in the final stages of testing, but the company has not yet applied for Food and Drug Administration approval.
Four companies have been working to develop pure forms of hydrocodone, the main ingredient in Vicodin, Lortab and other painkillers. They have been mostly quiet about their plans.
But William Marth, chief executive of the company’s North Wales, Pa.-based North American division, gave a preview of TD Hydrocodone during an investors’ conference in San Francisco on Tuesday.
“We believe that’s another product that will get approved and can be a three-, four-, $500-million product in a couple of years,” Marth said.
He said the drug could be on the market in the “relatively near future,” adding it should replace revenue lost when the patent on another Teva drug, the multiple sclerosis treatment Copaxone, expires in 2014.
A recording of the speech was posted on the company’s website on Thursday.
Teva did not respond to requests for more information. But documents filed with the National Institutes of Health show the company has been testing 12-hour, extended-release pills containing up to 45 milligrams of pure hydrocodone.
Existing medicines like Vicodin, which are not extended-release, contain no more than 10 milligrams of hydrocodone mixed with a non-addictive painkiller like acetaminophen or ibuprofen.
Another company, San Diego-based Zogenix, plans to file an application early this year for another pure hydrocodone product, Zohydro.
Purdue Pharma, the Stamford, Conn.-based maker of OxyContin, and Denmark-based Egalet are also working on hydrocodone pills, according to documents they have filed with the U.S. government.
Hydrocodone, oxycodone and morphine fall into a category of painkillers known as opiates because they are chemically similar to opium. They are extremely powerful and can create a physical dependence. Users who try to stop can suffer intense withdrawal symptoms, from muddled thinking to stomach cramps, heart palpitations and nausea.
Experts in pain management say opiates are needed for legitimate pain control, especially as the U.S. population gets older. Analysts say the market is worth billions of dollars.
But critics fear the new hydrocodone drugs could unleash a new wave of abuse like the one that accompanied the debut of OxyContin in the 1990s.
“It’s a prescription opiate arms race,” said Gregory Bunt, medical director of the Daytop Village chain of drug treatment centers in New York. “As the companies all compete they promote it to the various doctors, and it leads to an increase in prescriptions and makes more of those super-potent painkillers available for abuse.”
On Sunday, New York Sen. Charles Schumer sent a letter to the FDA warning against the approval of new hydrocodone products.
“I urge your agency to proceed with great caution before allowing these powerful narcotics to enter the market,” Schumer wrote.
New York Attorney General Eric T. Schneiderman issued a report Wednesday on the state’s “alarming” problem with prescription drug abuse. Oxycodone prescriptions have increased 82 percent and hydrocodone prescriptions by 16.7 percent between 2007 and 2010, the report said.
The TD in TD Hydrocodone stands for tamper deterrent, said Judson Clark, an analyst with the Edward Jones investment company who follows Teva. Addicts crush extended-release opiate pills to get the full impact of the medication and increase the high, so drug companies have been trying to develop tamper-resistant technologies to combat abuse.
Purdue Pharma has introduced a new form of OxyContin that “smooshes” instead of crumbling. Other companies are experimenting with chemical combinations or even encasing medicines in hard plastic pills that slowly leak out doses as they move through the digestive tract.
Zogenix says none of these methods is completely tamper-proof. Its Zohydro contains no tamper-resistant technologies.
Teva has not disclosed what tamper-resistant method it is using.
Clark said Teva’s $500 million-a-year sales goal for TD Hydrocodone is likely within reach. That’s about half the annual sales of a blockbuster drug like Viagra.
The drug should be quickly profitable because hydrocodone is already a proven painkiller, he said.
“You’re not going to have to have the sales force that you would need for a new drug that you’re taking to market that no one has heard of and, quite frankly, no one knows they need,” Clark said. “So in that sense, it will more or less sell itself.”
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